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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 205838


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NDA 205838 describes BRIVIACT, which is a drug marketed by Ucb Inc and is included in three NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the BRIVIACT profile page.

The generic ingredient in BRIVIACT is brivaracetam. One supplier is listed for this compound. Additional details are available on the brivaracetam profile page.
Summary for 205838
Tradename:BRIVIACT
Applicant:Ucb Inc
Ingredient:brivaracetam
Patents:1
Pharmacology for NDA: 205838
Mechanism of ActionEpoxide Hydrolase Inhibitors
Suppliers and Packaging for NDA: 205838
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRIVIACT brivaracetam SOLUTION;ORAL 205838 NDA UCB, Inc. 50474-870 50474-870-15 1 BOTTLE in 1 CARTON (50474-870-15) / 300 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/ML
Approval Date:May 12, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 27, 2024
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:⤷  Sign UpPatent Expiration:Feb 21, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER

Expired US Patents for NDA 205838

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc BRIVIACT brivaracetam SOLUTION;ORAL 205838-001 May 12, 2016 ⤷  Sign Up ⤷  Sign Up
Ucb Inc BRIVIACT brivaracetam SOLUTION;ORAL 205838-001 May 12, 2016 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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